Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery

NCT05624424 | Unknown Phase 4 DMC

• 1 other identifier: 2022-EA-2
• Study Type: interventional
• Target: 1,317
• Locations: 1 country
• Sites: 6

Brief Summary

Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources. Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.

Conditions

Emergence Agitation; Remimazolam Besylate; Perioperative Sedation; Laparoscopic Abdominal Surgery; Anesthesia, General

Keywords

Emergence Agitation; Remimazolam Besylate; Propofol; Sevoflurane; Laparoscopic Abdominal Surgery; Perioperative Sedation; Anesthesia, General

Outcome Measures

Primary Outcomes (2)

• The incidence of emergence agitation

  The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.

  Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.

• The incidence of emergence agitation

  The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.

  Duration from the time patients awakening to the time of departure from PACU, average 1 hour.

Secondary Outcomes (12)

• Systolic pressure

  "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".

• Diastolic pressure

  "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".

• Mean pressure

  "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".

• Heart rate

  "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".

• Recovery times

  Duration from the time patients awakening to the time of departure from PACU, average 1 hour.

Study Arms (3)

Remimazolam Besylate

EXPERIMENTAL

Induction of anesthesia Slowly inject Remimazolam Besylate 0.3\~0.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional Remimazolam Besylate (0.05 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Drug: Rematazolam Besylate; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil

Propofol

ACTIVE COMPARATOR

Induction of anesthesia Slowly inject Propofol 2\~2.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional Propofol (0.5 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Drug: Propofol; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil

Sevoflurane

ACTIVE COMPARATOR

Induction of anesthesia Slowly inject Etomidate 0.03 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional etomidate (0.03 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Drug: Sevoflurane; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil

Interventions

Rematazolam Besylate DRUG

Anesthesia was induced with Rematazolam Besylate 0.3\~0.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by remimazolam 1-3 mg/kg/h until the end of surgery.

Remimazolam Besylate

Propofol DRUG

Anesthesia was induced with Propofol 2\~2.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by remimazolam 5\~12 mg/kg/h until the end of surgery.

Propofol

Sevoflurane DRUG

Anesthesia was induced with etomidate 0.03 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by 2 %-3 % Sevoflorane until the end of surgery.

Sevoflurane

Sufentanil DRUG

Anesthesia was induced with Sufentanil 0.3\~0.5 ug/kg by intravenous injection after the LoC and BIS\<60.

Propofol; Remimazolam Besylate; Sevoflurane

Cisatracurium Besylate DRUG

Anesthesia was induced with cisatracurium besilate 0.2-0.3 mg/kg by intravenous injection after the LoC and BIS\<60, followed by 0.1 mg/kg/h Cisatracurium Besylate during the operation.

Propofol; Remimazolam Besylate; Sevoflurane

Remifentanil DRUG

After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.

Propofol; Remimazolam Besylate; Sevoflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years, sex was not limited;
• BMI 18-30kg/m2;
• Patients were scheduled for elective laparoscopic abdominal surgery under general anesthesia, the operation time 2h\~4h;
• ASA Ⅰ-III;

You may not qualify if:

• Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications;
• Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN;
• People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment;
• Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack;
• Female pregnant patients;
• Patients undergoing hepatobiliary surgery;
• Allergy to the experimental drug;
• Unable to cooperate to complete the test, the patient or family member rejected the participant;

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator

Study Sites (6)

People's Hospital of Ganzhou

Ganzhou, Jiangxi, China

Location

the First Affiliated Hospital of Gannan Medical College, Gannan Medical College

Ganzhou, Jiangxi, China

Location

The First People's Hospital of JiuJiang

Jiujiang, Jiangxi, China

Location

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

Location

Tumor Hospital of Jiangxi Province

Nanchang, Jiangxi, China

Location

Shangrao People's Hospital

Shangrao, Jiangxi, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Sevoflurane; Sufentanil; cisatracurium; Remifentanil

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids

Central Study Contacts

Fuzhou Hua, professor

CONTACT

+8615170238929; huafuzhou@126.com

Yang Fang

CONTACT

+8618370985324; ndfangyang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of remimazolam, propofol and sevoflurane.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a RCTs.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 22, 2022
• Study Start: November 15, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

CN (6)